Federal Officials Revise Controversial Peer Review Guidelines

John Graham, administrator of OMB's Office of Information and Regulatory Affairs

An outcry from the medicine and science communities over the Office of Management and Budget's (OMB) peer review revisions prompted the federal agency to release a second draft that received a more favorable response. According to individuals reviewing the second draft, the changes allow for a timely, accurate scientific review by the most qualified experts.

After receiving 187 comments, a majority of which criticized the proposal for wanting to scrutinize all data regardless of import, the OMB published a more detailed set of peer review guidelines. Many who initially opposed the OMB's first proposal, including AAMC officials, found the revisions more consistent with scientific study goals. OMB crafted the guidelines in order to set standards for how federal agencies use scientific peer review when determining regulatory policies.

"Whether one is entirely satisfied or unsatisfied with this version of peer review, I believe the OMB has been extraordinarily responsive to public comment," said David Korn, M.D., AAMC senior vice president of biomedical and health sciences research. "They made an effort to communicate with those who didn't like the draft and tried hard to respond to the best of their ability to add or make changes."

The first proposal sparked debate over whether scientists should be prohibited from serving as peer review panel members if they received grant money from a government agency. It also required all potentially publishable data to be scrutinized before public release, regardless of urgency. In addition, peer reviewers were required to attach their names and other identifying infor-mation to any comments they made during the review process. The AAMC criticized these initial proposals on the grounds that many layers of review could stymie any agency from releasing important information in a timely manner, Dr. Korn said.

According to the second draft, data that could have an urgent and immediate impact on public health and behaviors will not undergo an extensive peer review. However, if data could have an impact greater than $500 million in one year, the agency will require peer review. OMB revamped the peer review process to increase the quality level of scientific data disseminated by governmental agencies, said John Graham, administrator of OMB's Office of Information and Regulatory Affairs (OIRA), the group responsible for drafting the peer review guidelines.

"We need to be in a position of pro-regulation to protect public health and the environment," he said. "Reviewing science-based regulations helps stop bad regulations and impedes the outmoded ones."

Easing Restrictions

OMB's second draft lifted the tight restrictions placed on panel selection. Rather than exclude all federal-funded scientists, OMB advocated that agencies adopt the National Academy of Sciences peer review practices and analyze potential panelists individually. If scientists are peer reviewed before receiving an agency grant, they will be viewed as an independent, unbiased reviewer, according to the revised draft.

"Disqualifying scientists from participating because they are getting funding from the government is very broad and not justifiable," said Linda Greer, director of environmental and health prog- rams and senior scientist at the Natural Resources Defense Council.

OMB maintained a guideline that calls agencies to review any panel member's conflicts of interest including financial investments and consulting agreements. But some observers believe OMB's second draft could open the door for questions about panel members' credibility. Sidney Shapiro, a University of Kansas law professor and a board member of the Center for Progressive Regulation in Washington, D.C., agreed with Greer's contentions about panel selection but was disappointed that OMB would not require greater transparency and publish more of the data and information about the scientists reviewing it.

"The scientific community relies on the integrity of its data," Shapiro said. "You need to know if the peer reviewer tasked to edit is qualified. It needs to be done in the open."

However, any information a federal agency requires a scientist to provide before awarding grant money should also be required of a peer review panel mem-ber, said Sheila Jasanoff, Ph.D., J.D., Pforzheimer professor of science and technology studies at Harvard University. Having reviewer names attached to comments is standard practice, but anything beyond those grant requirements is questionable, she said.

"After a while, it becomes a question of where the privacy line has to be drawn," she said. "But when it extends to information about family members, a determination on how far it will go has to be made."

There are, however, some agency projects that are exempt from the peer review process. OMB excluded information regarding national security, foreign affairs or international treaty negotiations as well as researcher data that will not be presented on behalf of a federal agency.

-Whitney L.J. Howell

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